MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number M00545000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2013

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened for use in the common bile duct during a cytotechnology procedure performed on (b)(6) 2013.According to the complainant, during preparation, the brush was unable to retract back into the catheter.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.This event has been deemed reportable based on the investigation results: drive wire detached from handle cannula.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).Investigation results: visual evaluation of the returned device found residue on the brush which was fully extended when received.When the handle was actuated, the brush would not retract.The handle was taken apart, and it was discovered that the drive wire had detached from the handle cannula.The area where the drive wire had detached had no signs of either stretching or tearing.No remainder of the drive wire was found inside the handle cannula, indicating the drive wire had been pulled out of the cannula.The distal end of the handle cannula was flattened from the crimping process that secures the connection between the cannula and the drive wire.The complaint was confirmed; a device with a detached drive wire would not retract.The issue was identified during preparation, outside the patient.Therefore, the most probable root cause of the defects identified is handling damage.There is an investigation in place to address issues with brush retraction.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3647688
• MDR Text Key: 4182185
• Report Number: 3005099803-2014-01186
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/13/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16304293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1